MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS

Model Number	60-000-23-09
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that the implant did not fit the defect.
Additional Manufacturer Narrative
Investigation results indicated product made incorrectly due to error in image interpretation from scan.Corrective measures and training has taken place to eliminate future anomalies.Investigation results indicated product made incorrectly due to error in image interpretation from scan.Corrective measures and training has taken place to eliminate future anomalies.

• Brand Name: IPS
• Common Device Name: IPS
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8244130
• Report Number: 9610905-2018-00341
• Device Sequence Number: 1991973
• Product Code: GXN
• UDI-Device Identifier: 00888118100139
• UDI-Public: (01)00888118100139
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018
• Report Date (Section F): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-000-23-09
• Device Lot Number: 18011787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR